Role : VP, CMC & Technical Operations

Reports to: Chief Scientific Officer

Department: R&D

Level: VP

Location : Hybrid - Jersey City, NJ/ Brisbane, CA/ Remote

The Opportunity The VP of CMC & Technical Operations will lead all Chemistry, Manufacturing, and Controls (CMC) activities at Character, with a current focus on early development and clinical supply. This leader will drive process and analytical development, regulatory CMC strategy, and CDMO oversight to enable IND/IMPD filings and ensure reliable supply for Phase 1-3 clinical trials. Operating in a lean biotech environment, the VP will combine strategic leadership with hands-on execution.

Key Responsibilities

• CMC Strategy & Development
• Serve as the company’s subject matter expert for CMC, providing guidance to development teams, executive leadership and the board.
• Define and implement CMC strategy across drug substance, drug product, and analytical sciences.
• Lead IND/IMPD CMC authoring and regulatory interactions.
• Develop and execute efficient and timely clinical supply chain.
• Collaborate with clinical operations to ensure CMC plans support rapid entry into first-in-human and proof-of-concept studies.
• Anticipate and mitigate manufacturing and supply risks in a resource-efficient way.
• Manufacturing & Supply
• Oversee CDMO selection and management for GMP manufacturing.
• Direct tech transfer of processes into external manufacturing sites.
• Ensure timely supply of clinical trial materials and stability testing.
• Quality & Compliance
• Collaborate with Quality to establish and maintain phase-appropriate quality systems.
• Ensure regulatory compliance with evolving clinical-stage requirements.
• Leadership & Collaboration
• Partner closely with clinical, regulatory, and nonclinical functions to align CMC deliverables with program timelines.
• Represent CMC/Operations at the executive level and with external stakeholders.

Required Qualifications/ Experience

• Advanced degree (PhD, MS, or equivalent) in chemistry, biochemistry, engineering, or related field.
• 12+ years of biopharma experience with strong expertise in biopharma CMC development including leadership roles in process development, manufacturing, and regulatory CMC.
• Proven track record of taking programs from early through late stage development and commercial launch.
• Successful track record supporting IND/IMPD submissions and early clinical trial supply.
• Hands-on experience with CDMO management and GMP manufacturing for clinical programs.
• Entrepreneurial, execution-focused mindset suitable for a lean biotech environment.

Compensation & Benefits The annual pay range for this full-time position is $280,000-$320,000 + equity + benefits

This salary range represents the expected base compensation for this role and may vary based on factors including experience, skills, and level.

Benefits include a competitive salary, strong equity incentives, medical, dental, vision, 401(k), an accrued paid time off policy. Character is committed to recruiting, developing, and supporting colleagues from all backgrounds. We embrace diversity, equity, and inclusion as an integral part of our culture.

EEO Statement Character Biosciences is an equal opportunity employer and is committed to building a diverse and inclusive workforce. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other legally protected status.

Work Authorization Applicants must be authorized to work in the United States.